International open-label randomized comparative study of the efficacy and safety of Beclomethasone+Formoterol drug products, metered-dose inhaler, 100+6 Î¼g/dose (LLC â??PSK Pharmaâ??, Russian Federation) and Foster, metered-dose inhaler, 100+6 Î¼g/dose (Chiesi Farmaceutici S.P.A., Italy) in patients with partially controlled bronchial asthma.

PSK Pharma LLC0 sites120 target enrollmentStarted: TBDLast updated: November 24, 2021

Trial Snapshot

No summary available.

•Signed Informed Consent Form of the Patient Information Sheet (PIS) for participation in the clinical study
•- Male and female patients aged 18 through 70 at the time of signing the Informed Consent Form of PIS
•-Diagnosis of persistent BA, established according to the GINA guidelines, in 2018 at least 6 months before the screening visit
•-The need for broncholytic therapy with IGCS in combination with long-acting-Î²-agonists (LABA)

•- Patients with the need for selection of initial maintenance therapy of BA.
•- Contraindications to the use of iGCS, hypersensitivity to Beclomethasone, Formoterol, Salbutamol or any components of the study product.
•- Diagnosis of COPD, established according to the GOLD guidelines, 2018.
•- Use of glucocorticosteroids (GCS), either oral or for parenteral administration, less than 2 months before the screening visit (3 months for parenteral long-acting GCS).
•-Conditions requiring the use of systemic GCS at the time of the screening visit.

Sponsor

PSK Pharma LLC